CMS Seeks Guidance on Medicare Part D PBM Reform under the CAA 2026

On June 16, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a request for information (RFI) titled “Pharmacy Benefit Manager Compensation and Data Collection,” seeking industry input through comments on Section 6224 — part of the Medicare Part D provisions — of the Consolidated Appropriations Act of 2026 (CAA 2026). For additional background on Section 6224 (including the relevant definitions) and the broader PBM reforms enacted by the CAA 2026, see our prior blog post here. Section 6224 restricts the remuneration that pharmacy benefit managers (PBMs) and PBM affiliates may receive for services in connection with the utilization of covered Medicare Part D drugs, and establishes data reporting requirements. Both the remuneration restrictions and the reporting requirements are set to take effect on January 1, 2028.

The RFI offers an early window into how CMS is approaching implementation and enforcement of Section 6224, and where it sees the greatest risk of gaps in oversight. The RFI’s questions, organized into six categories, signal the agency’s priorities as it works toward the 2028 effective date. The discussion below distills what CMS appears most concerned with in each category.

Definition of Pharmacy Benefit Manager

As a threshold matter, CMS is focused on who actually falls within the definition of a PBM. The questions inquire about “related services” that are not expressly enumerated and about entities that perform PBM functions without identifying as a “pharmacy benefit manager.” They suggest that CMS is concerned with entities using different labels and structuring their operations in a way that may circumvent application of the Section 6224 requirements. Additionally, the questions related to indirect arrangements, use of intermediaries, and the payment terms (i.e., where does payment flow from/to, is payment related to utilization, formulary status, rebate value, etc.) between all the parties further highlight CMS’s intent to prioritize substance over form.

Definition of Affiliate

CMS’s questions regarding “affiliates” appear to reflect similar PBM industry-related concerns. CMS asks whether entities such as data vendors, group purchasing organizations/rebate aggregators, pharmacies, pharmaceutical wholesalers, and pharmacy benefit consultants should be treated as PBM affiliates subject to the CAA’s bona fide service fee restrictions. This is a clear indication that CMS is concerned with remuneration passing outside of regulated channels. By inviting comparisons to other regulatory and statutory definitions of “affiliate,” CMS appears to be testing how far the restrictions should reach and how to align them with existing frameworks. 

Definition of Bona Fide Service Fee

The bona fide service fee restriction is intended to ensure that PBM compensation reflects fair market value and is transparent. CMS is interested in understanding whether and in what form PBMs receive remuneration that is (i) not tied to services actually performed, (ii) for services that a PDP sponsor would not otherwise perform or contract for, and (iii) for fees that are contingent on drug price, discounts, rebates, coverage/formulary decisions, or the volume or value of business between the parties. CMS is also interested in “incentive payments” that fall outside the bona fide service fee definition yet remain otherwise permissible, suggesting that the agency intends to fully understand all avenues of remuneration to effectively enforce transparency.

Determination of Fair Market Value

To ensure bona fide service fees are at fair market value, CMS asks not only about methods commonly used to determine fair market value, but also whether those methods vary by entity type or take into account PBM market concentration and vertical integration. This indicates that CMS may be concerned with inflated pricing due to a PBM’s market leverage or its integration with key players in the pharmaceutical supply chain.

Pharmacy Payment

Here, CMS works to draw a boundary to ensure that the CAA 2026 does not disrupt legitimate pharmacy reimbursement practices. CMS clarifies that the CAA 2026 should not be construed to prohibit flat dispensing fees or reimbursement for ingredient costs, or to modify regulatory requirements or sub-regulatory guidance related to pharmacy payment. CMS appears to be requesting information on what arrangements do and do not fall within these carve-outs to protect pharmacy payments and understand whether remuneration may impermissibly flow through pharmacy payment channels. 

Data Collection

Finally, the data collection questions reveal CMS’s intent to create a comprehensive reporting scheme that allows for stronger PBM monitoring and enforcement over time. While the agency already contemplates collecting a wide variety of information including drug utilization and dispensing activity, drug costs and pricing, enrollee out-of-pocket spending, direct and indirect remuneration, pharmacy reimbursement, overall plan spending, and revenue retained by PBM or PBM affiliates, it asks for additional data elements that may aid its monitoring efforts.

Comments responding to the RFI are due by 5:00 p.m. on July 20, 2026. We will continue to monitor publication of the comments and other developments regarding implementation of the CAA 2026.
 

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